How to Design a Patient-Centric Clinical Trial Protocol?

Mansha Kapoor
April 13, 2023


Patient-centricity is a critical concept in clinical trials that guides the clinical trial research strategy. Patient-centricity means putting patients' needs and interests first and designing trials around their experiences.

A patient-centric approach to clinical trials improves patient retention rates. Patients are likelier to stick with a trial if they feel heard and valued by the researchers. This can lead to better data collection and more accurate results, as patients are more likely to comply with the study protocol when they feel they have a stake in the outcome.

Another important aspect of patient-centricity is its impact on patient outcomes. When researchers take the time to understand the patient's perspective and design trials tailored to their needs, they are more likely to produce effective treatments for patients. This is because patients have unique needs and experiences, and a one-size-fits-all approach to treatment is unlikely to be effective for everyone.

In addition, patient-centricity can improve the ethical implications of clinical trials. By prioritizing the patient's interests and needs, researchers are less likely to engage in exploitative practices or overlook the treatment's adverse effects. This can lead to more responsible and transparent research practices, crucial for building public trust in the clinical trial process.

A patient-centric approach to clinical trials requires researchers to be more proactive in engaging with patients and to be willing to adjust trial designs based on patient feedback. It also requires additional resources to be devoted to patient education and support. However, these challenges are outweighed by the benefits of a patient-centric approach, including better patient outcomes, improved ethical standards, and more accurate data collection.

Patient-centricity is a vital concept for clinical trials that can improve patient outcomes, data collection, and ethical standards. By prioritizing the patient's needs and interests, researchers can produce more effective treatments that better serve the needs of the patient population. It is a challenge, but it is one that researchers must embrace if there is progress in medicine.

Meaning of Patient-Centricity in Clinical Trials

Designing a patient-centric clinical trial requires a thorough understanding of the patient's perspective, including their needs, preferences, and expectations. It also requires a collaborative approach that involves patients, caregivers, and other stakeholders in the design process.

To achieve a patient-centric trial, researchers must prioritize patient-reported outcomes, incorporate patient feedback throughout the trial design and implementation, and use technology to facilitate patient engagement and data collection. This includes selecting outcome measures that are meaningful and relevant to patients and ensuring that trial protocols are easy to understand and follow for patients.

Patient-centeredness also means considering the practical challenges patients may face in a trial, such as travel, cost, and time commitments. Researchers should aim to minimize these barriers and make participation as convenient and accessible as possible.

A patient-centric clinical trial requires a mindset shift that prioritizes patient needs and experiences throughout the research process. By putting patients at the center of clinical trial design, clinical research quality, and relevance gets enhanced.

Patient-Centric Strategy in Clinical Trial Design

As the clinical trial design evolves, the architects must focus on the patient experience. This means prioritizing the well-being of those participating in clinical trials.  

1. Involvement of the Patient

First and foremost, we must involve patients in the clinical trial design process. Patients can provide invaluable insights into their illness, symptoms, and how their condition affects their daily lives. By incorporating patient perspectives, we can ensure clinical trials are designed to address the issues that matter most to patients. This can include everything from the trial's design to the endpoints. 

2. Minimizing the burden on the Patient

Another important patient-centric strategy is minimizing the burden on patients participating in clinical trials. Clinical trials can be a significant commitment, and we must do everything possible to reduce the patient burden. This can include offering remote participation options, ensuring that the trial location is accessible, and offering support and resources to help patients manage the impact of the trial on their daily lives. By prioritizing the patient experience, we can increase the likelihood that patients will participate in clinical trials and ensure that the results of those trials are more relevant to the patient population.

How to Include Patient Voice in a Clinical Trial Design

Including patient voice in a clinical trial, design can ensure that trials are relevant, meaningful, and patient-centered. To include the patient voice in clinical trial design, researchers can take several key steps. 

1. Identifying  patient population:

First, it is essential to identify the patient population targeted by the trial. This can be done by conducting focus events with patient groups or interviews with patients with the condition being studied. Identifying the patient population that will be the trial's focus is crucial.

In the context of clinical trials, this means that there is a  need to identify the patient population that is to be targeted and measure their specific needs, preferences, and expectations. Doing so creates a patient-centric clinical trial design that addresses their unique requirements.

For instance, if a clinical trial on a new medication for patients with diabetes is being conducted, the specific needs of patients with diabetes must be understood. This may include their blood sugar levels, dietary requirements, and lifestyle factors that impact their condition. Once these have been identified, designing a multi-faceted trial that considers them becomes easier. For instance, the demand could be to design a trial that tests the medication's effectiveness when taken with different types of food or that measures the impact of the medication on daily activities.

By understanding the unique needs of patients, a trial that addresses those needs and improves patient engagement and participation can be designed. As always, the key to success is to keep the patient at the center of all decision-making.

2.  Involving Patient Advocacy Groups

Second, researchers should seek input from patient advocacy groups and other stakeholders who deeply understand the patient's perspective. These groups can provide valuable insights into the patient experience and help identify key issues that must be addressed in the trial design.

3. Use of PROs

Third, researchers should consider using patient-reported outcomes (PROs) in the trial design. PROs are measures of health status that are reported directly by patients. They can help capture the patient's perspective on the impact of the condition being studied and the effectiveness of the intervention being tested.

4. Participation of Patients in Advisory Boards for Designing Clinical Trials

Finally, researchers should involve patients in the trial design process whenever possible. This can include inviting patients to participate in advisory boards or other committees responsible for designing the trial. By involving patients in the design process, researchers can ensure that the trial is designed with the patient in mind and that the patient's perspective is incorporated into every aspect of the trial.

5. Using Real World Data

Using real-world data means utilizing electronic health records, claims, registries, and other data sources like dashboards, bespoke linkages, physician notes, low-intervention observational studies, collaboration with Contract Research Organizations,  and Pharmacovigilance Analysis. This helps identify appropriate medicines for patient groups and subgroups and reduces risk. Real-world evidence provides information about a broader cross-section of society and helps clinicians and researchers understand their work and area of research more in detail and depth.

How Does a Patient-Centric Clinical Trial Help in Enhancing Patient Enrollment?

A patient-centric design of clinical trials is essential to ensure effective patient enrollment and retention. Patient-centric design involves understanding the patient's needs, preferences, and concerns and tailoring the clinical trial to meet those needs. For instance, if patients are concerned about the time commitment required for a trial, a patient-centric design might incorporate a more flexible schedule or offer virtual visits.

Moreover, a patient-centric design can improve patient recruitment by increasing awareness and trust in the trial. This can be achieved through clear and accessible communication about the trial's purpose, potential benefits, and risks. It is also important to involve patient advocates in the trial design to ensure patient perspectives are incorporated.

Additionally, a patient-centric design can reduce the burden of participation in clinical trials. Many patients may hesitate to enroll in trials due to concerns about the potential risks, inconvenience, or impact on their daily lives. By designing more patient-friendly trials,  these concerns can be alleviated, and patients can be encouraged to participate.

A patient-centric design can also improve patient retention in clinical trials. Patients who feel their needs and concerns are being heard and addressed will likely stay engaged and committed to the trial. This can be particularly important in longer-term trials, where patient drop-out can undermine the validity and reliability of the study results.

Finally, a patient-centric design can lead to better outcomes for patients and the broader healthcare system. By incorporating patient perspectives and feedback into the trial design, trial outcomes can become more relevant and meaningful to the patients. This helps accelerate the development of new treatments and therapies that are more effective, efficient, and patient-centered.

Therefore a patient-centric design is not only important for patient enrollment in clinical trials but also for the overall success of the trial and the impact it can have on patients and healthcare. By prioritizing the needs and preferences of patients, cr trials can be created that are more accessible, trustworthy, and effective in advancing medical research.

Role of Health Literacy in Designing a Clinical Trial

Health literacy is a crucial component of designing a patient-centric clinical trial. Patients who are participating in clinical trials must understand the risks and benefits of the trial, as well as the requirements and expectations of the trial protocol. Suppose patients need a better understanding of these factors. In that case, they may not be able to make informed decisions about their participation, which can compromise the validity and safety of the trial.

Patients with low health literacy may need help with following the trial protocol and may need help comprehending the importance of adhering to the trial procedures. This can lead to errors and inaccuracies in data collection, which can have a negative impact on the results of the trial.

Clinical trial designers must prioritize health literacy when developing trial materials and communications to address these challenges. The architects of a clinical design have to use plain language and avoid jargon or technical terms that may be difficult for patients to understand. Trial materials should also be culturally sensitive and tailored to the needs and preferences of the target patient population.

Patient education and training can also help improve health literacy and ensure patients are fully informed about the trial. This can include providing patients with educational materials and offering training sessions on the trial procedures and expectations.

Ultimately, prioritizing health literacy in the design of a patient-centric clinical trial can help to ensure that patients fully understand the risks and benefits of the trial and can make informed decisions about their participation. This can improve the quality and accuracy of the trial data while also ensuring the safety and well-being of participating patients.

Effective Ad Campaigns

Ad campaigns are essential in attracting a diverse patient population to clinical trials. Clinical trial recruitment can be slow without effective ads, leading to delays in developing new treatments. Ad campaigns that speak directly to patients and their families can help overcome any stigma associated with participating in clinical trials and provide much-needed information on the benefits of participating.

Moreover, ad campaigns can ensure clinical trial participants represent the broader population. Clinical trials require diverse patient populations to confirm the results apply to different groups. Effective ads that reach out to underrepresented communities can help improve the diversity of participants and lead to more inclusive trial results.

Effective ad campaigns are crucial for patient-centric clinical trials. They help attract a diverse patient population, overcome stigma, and provide information about the benefits of participating. Ad campaigns prioritizing patients' needs and experiences will help ensure that clinical trials are conducted in a way that ultimately benefits patients and leads to the development of life-saving treatments.

What are the Elements of a Patient-Centric Clinical Trial Landing Page?

A well-designed landing page can play a crucial role in engaging patients and encouraging them to participate in clinical trials.

A clinical trial website should have a landing page that must be easy to navigate and accessible to patients. It should provide clear and concise information about the study, such as the purpose of the trial, eligibility criteria, and potential risks and benefits.

It should be patient-centric in its language and design. Patients need to feel that the trial is designed for them and their needs. Therefore, the landing page should provide information on how the study can benefit patients, how it aligns with their healthcare goals, and how they can contribute to medical research.

 The landing page should emphasize the safety and privacy of patients. Patients need to feel confident that their personal information is safe and that the study is conducted ethically and transparently. Therefore, it should provide clear information on how patient data is collected, used, and protected.

Finally, the landing page should provide multiple ways for patients to connect with the study team. Patients may have questions or concerns about the study, and it is crucial to provide them with various communication channels, such as email, phone, or online chat.

In conclusion, a patient-centric clinical trial landing page should be informative, accessible, patient-centric, and safety-focused and provide multiple channels for patient communication. 

There should be a provision for messaging that goes out from the headline and subheadline to the calls to action. Messaging plays a significant role in guiding a web visitor; therefore, the headline should make a clever statement and immediately follow it up with specific, precise information about the clinical study that is about to be launched. Cloudy information confuses a potential participant and discourages him from showing interest. 


When designing a patient-centric clinical trial, there's one key concept to keep in mind: empathy. Clinical trials are often designed solely with the goals of researchers and pharmaceutical companies. But if patients are to be enrolled and retained, patient experience should be prioritized.

Mahalo is the first Digital Health Platform to accelerate digital health app development and clinical evidence collection. Mahalo is a highly customizable modern clinical trial platform that accelerates study startup, recruitment, screening, and more — reducing the cost of running your trial. With Mahalo, you reduce the risk of patient recruitment cost overruns, patient non-adherence, high dropout rates, and severe adverse events. Reach out to us to design your clinical trial today!


Experience Mahalo's transformative platform. Book a demo today!

Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.